For the healthcare industry, the pain caused by a needle prick is more than just a momentary annoyance. Needle pain and fear is thought to have a more serious effect on compliance with immunizations, injectible drugs and blood draws.
“If pain decreases, compliance goes up, and if compliance goes up, outcomes get better and costs go down,” explained Tim O’Malley, CEO of Innova Medical Design.
Rather than trying to replace needles in medicine with painless microneedles or light sensing technology, Innova Medical Design is adding onto them with a combination of neurostimulation and vibration, with the goal of blocking pain signals at the sight of an injection, blood draw or IV.
The company’s pain relief devices are based on the gate control theory of pain, which projects that pain messages encounter “nerve gates” in the spinal cord that control whether they will reach the brain. Sensory nerve fibers triggered by other kinds of stimulation, like rubbing your elbow after you bump it, are thought to essentially reach the nerve gates faster and override or block the pain signals.
Innova has developed a technique that combines vibration with a few kinds of transcutaneous electrical nerve stimulation (TENS) to “occupy” nerve endings and reduce or block pain. Its first two products apply the technique to pediatrics and diabetes.
At the top of the company’s pipeline is an adhesive patch that’s placed on a child’s arm when he’s about to get a shot or have an IV inserted. Embedded in the patch are two dual-layer electrodes. When a reusable stimulation device is placed on top of the electrodes, it transmits the TENS and vibration signals that create a comfortable sensation on the arm during needle insertion.
O’Malley said the pediatrics market seemed to be the lowest-hanging fruit for this technology, as fear of needles tends to be obviously troublesome in children. But the company would also like to move into additional consumer pain models once it gets an initial device on the market. To get that initial product on the market, O’Malley said he’s looking to raise about $2.5 million to $3 million to complete a final design of the patch and obtain 510(k) FDA clearance.
Additional funding beyond that would allow Innova to simultaneously commercialize a lancet it’s been developing with the same TENS/vibration mechanism, to block daily pain for diabetics when they check their blood sugar and inject insulin. In a pilot test with 24 people, two-thirds of the subjects experienced an average reduction of pain of over 60 percent when using the device, O’Malley said. It would only cost two or three dollars more to make than a standard lancet, he added.
Because both the lancet and TENS technology have been around for decades, O’Malley sees a well-defined and relatively quick regulatory path for the devices. “We’d like to produce a new product every nine months for three years after initial launch,” he explained.
Minneapolis-based Innova formed in early 2009 out of a relationship between O’Malley, a medical device executive with a background in diabetes and neurology products, and Dr. Mel Vallero, an emergency medicine physician at Kaiser Permanente.
“What was attractive about this particular idea for needle pain is that Dr. Vallero, being an ER doctor, had a very pragmatic sense of doing something rather basic,” O’Malley said. “There is more emphasis now on the more pragmatic things that we do every day, where if we could improve those, the significance to compliance and cost could be as significant as those big medical breakthroughs.”
[Image credit: Innova Medical Design]